PMA P140003S099
- Device
- Impella CP with SmartAssist, Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- Product code
- OZD
- Decision date
- 2022-10-28
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval for the use of an alternative programmed microcontroller.
Current openFDA PMA Record#
- Device
- Impella CP with SmartAssist, Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S099
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2022-10-28
- Decision code
- APPR
- Date received
- 2022-05-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of an alternative programmed microcontroller.